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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For Quarter Ended Commission File No.
SEPTEMBER 30, 1996 0-26770
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NOVAVAX, INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 22-2816046
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
8320 GUILFORD ROAD, COLUMBIA, MD 21046
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(Address of principal executive offices) (Zip code)
(301) 854-3900
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Registrant's telephone number, including area code
Indicate by check mark whether the Registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No
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The number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date:
Common Shares Outstanding at November 4, 1996
10,560,983
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NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended September 30, Nine months ended September 30,
1996 1995 1996 1995
----------- ----------- ----------- -----------
Revenues:
Sales revenues $ 11,327 $ - $ 38,324 $ -
Royalty revenues
from former parent - 70,637 - 202,648
------------ ------------ ------------ ------------
Cost and expenses:
Selling, general
and administrative 286,429 845,525 1,262,912 2,093,999
Research and development 777,167 840,022 2,513,152 2,248,433
Interest expense
to former parent - 434,419 - 1,315,051
Interest income (31,653) (929) (121,107) (1,936)
------------ ------------ ------------ ------------
Net loss $(1,020,616) $(2,048,400) $(3,616,633) $(5,452,899)
=========== =========== =========== ===========
Net loss per common and
common equivalent share $ (.10) $ (.21) $ (.36) $ (.55)
====== ====== ====== ======
Weighted average number of
common and common
equivalent shares 10,055,661 9,937,936 9,998,028 9,937,936
=========== =========== =========== ===========
The accompanying notes are an integral part of the
consolidated financial statements.
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NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, December 31,
ASSETS 1996 1995
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Current assets:
Cash and equivalents $ 2,141,138 $ 4,634,236
Receivable from former parent, net - 54,754
Prepaid expenses 125,374 72,209
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Total current assets 2,266,512 4,761,199
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Furniture and equipment - at cost 2,163,921 2,106,774
Accumulated depreciation (864,018) (705,776)
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1,299,903 1,400,998
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Patent costs, net of accumulated
amortization of $398,819 and
$323,069 in 1996 and 1995,
respectively 1,545,007 1,357,547
Deferred tax asset 100,000 -
Other assets 84,886 9,800
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$ 5,296,308 $ 7,529,544
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Current maturities of Long-term debt $ 8,106 $ -
Accounts payable 319,054 391,887
Accrued payroll 33,902 38,900
Due to former parent, net 63,001 -
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Total current liabilities 424,063 430,787
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Long-term debt,
less current maturities 19,496 -
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Commitments and contingencies
Stockholders' equity:
Preferred stock, $.01 par value,
2,000,000 shares authorized - -
Common stock, $.01 par value,
30,000,000 shares authorized,
10,055,983 and 9,937,936 shares
issued and outstanding in 1996 and
1995, respectively 100,560 99,379
Additional paid in capital 30,499,583 30,188,122
Deficit (24,917,812) (21,301,179)
Deferred compensation on stock
options granted (829,582) (1,887,565)
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4,852,749 7,098,757
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$ 5,296,308 $ 7,529,544
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The accompanying notes are an integral part of the
consolidated financial statements.
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NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine months ended September 30,
1996 1995
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Cash flows from operating activities:
Net loss $(3,616,633) $(5,452,899)
Reconciliation of net loss to net cash
used by operating activities:
Non-cash compensation expense 1,057,983 -
Depreciation and amortization 233,991 147,116
Provision for deferred taxes (100,000) -
Changes in operating assets and liabilities:
Accounts receivable - 475,000
Prepaid and other assets (128,251) (26,983)
Payable to/receivable from
former parent 230,474 -
Accounts payable and accrued expenses (77,831) (72,552)
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Net cash used by operating activities (2,400,267) (4,930,318)
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Cash flows from investing activities:
Capital expenditures (29,545) (61,427)
Deferred patent costs (283,142) (183,639)
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Net cash used by investing activities (312,687) (245,066)
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Cash flows from financing activities:
Payable to former parent - 3,437,696
Notes payable to former parent - 1,738,980
Proceeds from exercise of common
stock options 219,856 -
----------- -----------
Net cash provided by financing activities 219,856 5,176,676
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Net change in cash and equivalents (2,493,098) 1,292
Cash and equivalents at beginning of year 4,634,236 16,221
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Cash and equivalents at September 30, 1996 and 1995 $ 2,141,138 $ 17,513
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The accompanying notes are an integral part of the
consolidated financial statements.
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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Basis of Presentation
The accompanying consolidated financial statements include the accounts of
Novavax (formerly Molecular Packaging Systems, Inc.), its wholly-owned
subsidiaries (Micro-Pak, Inc. ("Micro-Pak") and Micro Vesicular Systems, Inc.
("MVS"), and Lipovax, Inc. ("Lipovax", formerly known as Novavax, Inc.)). All
significant intercompany accounts and transactions have been eliminated. These
statements have been prepared by Novavax, Inc. without audit, pursuant to the
rules and regulations of the Securities and Exchange Commission, and reflect
all adjustments which, in the opinion of management, are necessary for a fair
statement of the results for the interim periods presented. All such
adjustments are of a normal recurring nature.
The financial statements for the period January 1, 1995 through September
30, 1995 have been prepared on a combined basis from books and records
maintained by IGI, Inc. ("IGI"). These combined financial statements reflect
the financial position and results of operations of the combined companies at
their historical bases, including allocations of certain costs by IGI.
Certain information in footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles
has been condensed or omitted pursuant to such rules and regulations, although
the Company believes the disclosures are adequate to make the information
presented not misleading. It is suggested that these financial statements be
read in conjunction with the financial statements and the notes thereto
included in the Company's Annual Report on Form 10-K for the year ended
December 31, 1995.
2. Net Loss Per Common Share
Net loss per share of common stock is computed by dividing net loss by the
weighted average number of shares of common stock and common stock equivalents
outstanding during the three and nine month periods ended September 30, 1996.
Options granted subsequent to December 12, 1995, (the "Distribution Date") the
date on which the Company's former parent, IGI, Inc., distributed its majority
interest in Novavax to the IGI stockholders (the "Distribution") are
antidilutive and therefore have not been included in shares outstanding. The
net loss per common and common equivalent share calculated for the three and
nine month periods ended September 30, 1995 is based upon weighted average
shares outstanding of 9,937,936 representing primarily shares issued in
connection with the recapitalization. These shares have been treated as
outstanding as if the transaction had occurred on January 1, 1995.
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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, continued
3. Transactions with Former Parent
Charges
Through the Distribution Date, IGI charged Novavax for expenses incurred
on its behalf, including executive, legal, accounting, data processing,
consulting, cash management, human resources and employee benefits. These
costs were allocated on a variety of methods, including:
- Specific identification based on estimates of time and services provided
- Relative identification allocated based on Novavax's relationship to the
entire pool of beneficiaries
The allocation methods, while reasonable under the current circumstances,
may not represent the cost of similar activities on a separate entity basis.
Such costs of $296,786 and $890,358 have been included in general and
administrative expenses, along with interest expense of $434,419 and
$1,315,051, for the three and nine month periods ended September 30, 1995,
respectively.
Transition Services
Novavax entered into agreements with IGI under which IGI provided certain
executive and administrative services for a period not to extend beyond June
30, 1996. Fees for such services were based on IGI's costs. The agreement was
terminated on June 30, 1996. Costs of $230,474 had been incurred for the six
month period ended June 30, 1996. No additional charges have been incurred
for the three-month period ended September 30, 1996. These charges have been
offset in part by receivables due from IGI and recorded as a payable to former
parent on the balance sheet.
Revenues
Prior to the distribution, Novavax earned royalties from IGI at 10% of the
sales of the licensed products. The agreements were terminated in connection
with the Distribution and execution of a license agreement with IGI (the"IGI
License Agreement"). The IGI License Agreement, which was entered into as a
method of transferring the Novavax technologies was structured as a license
agreement to address various considerations of the Distribution, including tax
and financing considerations.
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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, continued
4. Income Taxes
Novavax has recorded no net provision for income taxes in the accompanying
financial statements due to the existence of net operating losses. The Company
recognized a deferred tax asset in the amount of $100,000 for
alternative-minimum tax liability, which was paid in the second quarter,
related to the tax effect of the licensing agreement.For tax purposes, the
transaction was treated as income for the period ended December 31, 1995.
Novavax has recorded the license at its carryover basis because the
transaction is a transfer made among entities under common control. As all
costs of development for this technology have been expensed with the exception
of the patents retained by Novavax, the historical basis is zero.
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NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
The following discussion may contain "forward-looking" statements, as that
term is defined by (i) the Private Securities Litigation Reform Act of 1995
(the "Reform Act") and (ii) in releases made by the Securities and Exchange
Commission from time to time. Such statements should be read in conjunction
with the cautionary factors described in Exhibit 99 attached to the Company's
Annual Report on Form 10-K for the year ended December 31, 1995 and
incorporated into this discussion by this reference and the consolidated
financial statements and related notes. The Company's future operating results
may be affected by various trends and factors that are beyond the Company's
control. These include among other factors, changes in general economic
conditions, rapid or unexpected changes in technologies and uncertain business
conditions that affect the pharmaceutical and vaccine industries. Accordingly,
past results and trends should not be used by investors to anticipate future
results or trends.
RESULTS OF OPERATIONS
Novavax is a biopharmaceutical company focusing on the research and
development of proprietary topical and oral drug delivery technologies. The
Company has also developed vaccines and vaccine adjuvants. The Company has
incurred net losses since inception and will continue to incur losses for
several years. Net losses will vary from quarter to quarter depending upon the
number of products the Company may have in clinical trials and the phases of
the clinical trials. Until the second quarter of 1996, Novavax had recorded
revenues from two sources: (i) research revenues from industry partners in
consideration of either exclusive licenses or technology applications and (ii)
royalty revenues that were attributable to product sales by IGI, Inc., the
Company's former parent. Revenues from the sale of scientific prototype
vaccines and Novasome adjuvants have been recorded in the second and third
quarters of 1996.
Costs and expenses for Novavax consist of the following items:
1. Selling, general and administrative expenses that include all costs
associated with the marketing of the technology to potential industry partners,
related costs associated with the continuing endeavor to raise capital; and
management and administrative expenses.
2. Research and development expenses, which include scientific staff,
facility costs, supplies and other costs related to the ongoing development of
the Novavax technologies; and
3. Interest expense that has been charged to Novavax by IGI for borrowings
and notes due to IGI through December 12, 1995.
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NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Three months ended September 30, 1996 compared to 1995
The net loss for the third quarter ended September 30, 1996 of $1,020,616
was $1,027,784, or 50% lower than the net loss of $2,048,400 for the third
quarter ended September 30, 1995. The net loss for the third quarter of 1996
was $190,566 and $364,219 less than the net losses in the first and second
quarters of 1996, respectively.
Revenues of $11,327 were recognized during the three months ended
September 30, 1996 from the sale of scientific prototype of vaccines and
adjuvants. Research and development contracts should produce comparable
revenues through the end of 1996. Royalties from IGI of 10% of licensed
product sales, or $70,637 accounted for the revenues in the three months ended
September 30, 1995.
Selling, general and administrative expenses were $286,429 for the three
months ended September 30, 1996 compared to $845,525 in the same three months
of 1995. The termination of the transitional services agreement with IGI on
June 30, 1996 and the absence of certain 1995 expenses related to the spinoff,
including transaction costs and costs of $296,786, which were allocated from
IGI to Novavax based on Novavax being a separate public company, were
significant factors in the $559,096, or 66% decrease.
Research and development expenses were $777,167 and $840,022 for the three
months ended September 30, 1996 and 1995, respectively. The decrease in these
expenses related principally to the reduction of laboratory supply inventories
in preparation for the impending company move to Columbia, Maryland and the
completion of the Phase I human clinical safety study of Helicore(TM), an oral
non-antibiotic antibacterial preparation developed to eradicate Helicobacter
pylori bacteria.
Interest income of $31,653 was recorded in the three months ended
September 30, 1996 compared with net interest expense of $433,490 related to
borrowing from IGI in the three months ended September 30, 1995.
Nine months ended September 30, 1996 compared to 1995
The net loss of $3,616,633 for the nine months ended September 30, 1996
was significantly lower than the net loss in the first nine months of 1995.
The 1996 net loss included $1,057,983 of non-cash compensation expense related
to the amortization of below-market priced stock options issued at the time of
the spinoff and $233,991 of depreciation and patent amortization expense.
Revenues of $38,324 were recognized during the nine months ended September
30, 1996 from the sale of scientific prototype vaccines and Novasome adjuvants.
Novavax earned royalties from IGI of 10% of licensed product sales, or $202,648
in the nine months ended September 30, 1995.
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NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Nine months ended September 30, 1996 compared to 1995, continued
Selling, general and administrative expenses were $1,262,912 for the nine
months ended September 30, 1996 compared to $2,093,999 in the first nine months
of 1995. Nonrecurring charges of $230,474 were incurred through June 30, 1996
for transitional services provided by IGI. This agreement was terminated June
30, 1996 and no additional charges have been recorded. Costs of $890,358
included in the 1995 expenses were allocated from IGI to Novavax based on
Novavax being a separate public company.
Research and development expenses were $2,513,152 and $2,248,433 for the
nine months ended September 30, 1996 and 1995, respectively. The increase in
these expenses related primarily to non-cash compensation charges of $1,050,421
related to the amortization of below-market priced stock options issued at the
time of the spinoff. Reduced spending and other efficiencies have caused the
Company to focus its efforts on the development of certain human pharmaceutical
applications of the Novavax technologies in connection with FDA human clinical
trials.
Interest income of $121,107 was recorded in the nine months ended
September 30, 1996 compared with net interest expense of $1,313,116 related to
borrowing from IGI in the nine months ended September 30, 1995.
Liquidity and Capital Resources
The Company used $2,493,098 of its cash resources during the nine-month
period ended September 30, 1996. In addition to revenues of $38,324, the
Company received proceeds of $219,856 from the exercise of stock options.
These proceeds enabled the Company to maintain an average monthly cash "burn
rate" of less than $280,000. This rate is expected to increase moderately as
the Company's products move through the FDA regulatory process. The Company's
other expenditures were primarily attributable to preclinical product
development, legal expenses associated with the protection of the Company's
intellectual property, and administrative expenses.
Novavax expects to incur substantial operating losses due to the
time-consuming research, preclinical development and clinical trials necessary
to bring pharmaceutical products to market. These losses will continue until
such time as product sales and royalty payments generate sufficient revenue to
fund its continuing operations. In addition to funding the continuing
operating losses, the Company's rapid evolution from a research phase company
to a development stage biopharmaceutical company with products in human
clinical trials has prompted the need for expansion.
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NOVAVAX, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS
Liquidity and Capital Resources, continued
On October 31, 1996, the Company completed the relocation of its
administration offices and pharmaceutical laboratories to a leased facility
in Columbia, Maryland. The newly leased space allows for the development
of our pharmaceutical products. The Company retained approxmiately 1750
square feet of space in its Rockville facility for its animal laboratory
and for the research, development and production of vaccines and adjuants.
On October 30, 1996, Novavax received $1,757,871, net of fees and
expenses, from the sale of 505,000 common shares that were privately placed
with accredited institutional investors by Vector Securities International,
Inc. Novavax estimates that the money received from the sale of the
privately placed stock, along with its existing cash resources, will be
sufficient to finance its operations at current levels of development
activity for approximately 12 months. During this time, Novavax will seek
to obtain additional funds through public or private equity or debt
financings, collaborative arrangements with pharmaceutical companies, or
from other sources. There can be no assurance that additional funding or
bank financing will be available at all or on terms which will permit
successful commercialization of Novavax or Novavax's technology and
products. If adequate funds are not available, Novavax may be required to
significantly delay, reduce the scope of or eliminate one or more of its
research or development programs, or seek alternative measures to finance
its operations including arrangements with collaborative partners or others
that may require Novavax to relinquish rights to certain of its
technologies, product candidates or products.
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NOVAVAX, INC. AND SUBSIDIARIES
PART II OTHER INFORMATION
Item 1 - Legal Proceedings
There were no material developments in the litigation previously described
in the Company's Annual Report on Form 10-K for the year ended December 31,
1996.
Item 2 - Changes in Securities
The constituent instruments defining the rights of the holders of any
class of securities were not modified nor were the rights evidenced by any
class of registered securities materially limited or qualified during the
period covered by this report.
Item 3 - Defaults Upon Senior Securities
No defaults occurred during the period covered in this report.
Item 4 - Submission of Matters to a Vote of Security Holders
None
Item 5 - Other information
None
Item 6 -exhibits and Reports on Form 8-K
(a) Exhibits:
Exhibit 11 - Computation of Net loss Per Common Share
Exhibit 27 - Financial Data Schedule
(b) Reports on Form 8-K
None
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NOVAVAX, INC. AND SUBSIDIARIES
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
NOVAVAX, INC.
(Registrant)
Date: November 14, 1996
By: /s/ Elaine T. Bennett
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Elaine T. Bennett
Vice President
(Principal Financial
and Accounting Officer)
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